Noticias y novedades
How to Obtain CDSCO Approval for Medical Devices
Obtaining CDSCO (Central Drugs Standard Control Organization) approval in India is a crucial step for entering this growing market. The process starts with submitting a detailed application that includes the Intended Use of your product and provides evidence of safety [...]
When Should You Involve a CRO in Medical Device Development?
The optimal time to engage a Contract Research Organization (CRO) in your medical device’s development is as early as possible, ideally during the initial planning phase of your clinical study. Involving a CRO from the outset ensures a study [...]
New Revision of European Medical Device Regulations: Towards Greater Transparency and Safer Access for All
In response to current challenges regarding the accessibility and safety of medical devices, the European Parliament approved a landmark resolution on October 23, 2024, to revise the regulatory framework for these products across the European Union. This urgent update [...]
Is the TGA Sponsor Responsible for the Quality or Safety of Your Products?
No, it’s essential to understand that in Australia, the role and responsibilities of a sponsor are distinct from those of a manufacturer. A sponsor registered with the Therapeutic Goods Administration (TGA) ensures the product complies with Australian regulations and [...]
Looking for an FDA Agent? 5 Key Factors to Consider
If you’re selecting an FDA Agent for the U.S. market, certain factors can make all the difference. Here are five essential aspects to ensure you’re making a smart, strategic choice: Expertise in FDA Regulations A strong FDA Agent has [...]
What is the IFU and why is it crucial for medical devices?
The Instructions for Use (IFU) is essential for every medical device. Here's why it's so important: 1. User safety: It provides detailed instructions to ensure safe use, reducing the risk of errors. 2. Intended use: It specifies how and [...]
Discover how to register your medical devices in Europe: an essential guide for manufacturers outside the EU!
Are you a manufacturer outside the EU and wondering how the medical device registration process works in Europe? Here’s an essential overview to guide you through the regulatory system! Step 1: Actor Registration The first step is providing key information [...]
Clinical Research in Medical Devices: What Role Does the Manufacturer Play?
Clinical research is fundamental to ensuring the safety and effectiveness of medical devices. But what are the key responsibilities of the manufacturer in this process? Here’s what you need to know: Study Design: The manufacturer must ensure that the [...]
Exciting news! We’re heading to CMEF, the International Medical Device Fair in Shenzhen!
Join us from October 12 to 15, 2024, at the Shenzhen World Exhibition and Convention Center. Our team is excited to meet industry professionals and discuss how we can support your regulatory needs in the medical device sector. 📌 [...]
